Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, eradication, hybrid therapy, concomitant therapy
Brief summary
The aim of the study is to compare the effectiveness of two therapeutic protocols in the treatment of Helicobacter pylori infection. The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. In other words, in both therapeutic groups we expect successful treatment of Helicobacter pylori infection in or more than 90 % of patients. In other studies, both therapeutic options have the same efficacy in treating H. pylori infection. On the other had there are no studies available in Croatia to compare the effectiveness of these therapeutic options so far, which is the main objective of our research. The secondary goals of our study will be: the existence of differences in the occurrence of possible side effects, as well as the compliance between patients in both therapeutic options. It is also our aim to compare the quality of life of patients with Helicobacter pylori infection before and after treatment, via a questionnaire that is common for this purpose. The study is expected to include a total of 120 patients (60 patients in each therapy group), and the planned duration is 12 months.
Interventions
Amoxicillin ('Amoksicilin') 1 g bid 14 days.
DRUGHybrid therapy
Amoxicillin ('Amoksicilin') 1 g bid 14 days
Sponsors
University Hospital of Split
University of Split, School of Medicine
Antonio Mestrovic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Helicobacter pylori infection (documented by: positive antigen stool test, or positive urease rapid test obtained during upper endoscopy, or Helicobacter pylori in histological finding, or positive C-urea breath test; according to recent Maastricht V guidelines; * written informed consent
Exclusion criteria
* age under 18 * previously treatment of Helicobacter pylori infection * malignancy of stomach or other site * history of taking proton pump inhibitors, H2 antagonist, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in previous month * significant underlying disease (renal failure, psychiatric disorders) * history of allergic reactions to any medications used in study * refuse to participate in study * breastfeeding and pregnancy * quitting the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori status one month after treatment. | One month after finishing with therapy. | Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection. | One month after finishing with therapy. | Compliance will be measured by counting pills that were taken during therapy. More than or equal 80 % of taken pills will be consider as good compliance |
| Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection. | One month after finishing with therapy. | Patients will be ask to report any adverse effect occured during treatment. They will be divided in groups according to degree of limiting daily activities: no adverse effects; mild (no limit of activities); moderate (partially limited activities); severe (completely limited activities). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life before and after eradication therapy | One month after therapy | Quality of life before and after eradication (both groups combined) therapy will be reported by The Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. GSRS questionnaire: 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents no discomfort at all, 2 - minor discomfort, 3 -mild discomfort, 4 - moderate discomfort, 5 -moderately severe discomfort, 6 -severe discomfort, 7 - very severe discomfort |
| Quality of life before and after eradication therapy between hybrid and concomitant group. | One month after therapy | Quality of life before and after eradication therapy will be reported by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire comparing both groups. GSRS questionnaire: 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents no discomfort at all, 2 - minor discomfort, 3 -mild discomfort, 4 - moderate discomfort, 5 -moderately severe discomfort, 6 -severe discomfort, 7 - very severe discomfort |
Countries
Croatia
Outcome results
None listed